That’s right folks, FDA has issued it’s final guidance for developers of mobile medical applications.
The FDA is focusing its oversight on mobile medical apps that:
- are intended to be used as an accessory to a regulated medical device – for example, an application that allows a health care professional to make a specific diagnosis by viewing a medical image from a picture archiving and communication system (PACS) on a smartphone or a mobile tablet; or
- transform a mobile platform into a regulated medical device – for example, an application that turns a smartphone into an electrocardiography (ECG) machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack.
To read the document or simply to find out more, surf on to the official press release here.